3/09/2004 @ 12:11PM

The Ephedra Battle Moves To The Courts

NVE Pharmaceuticals
today became the first diet pill company to sue the federal government for banning ephedra, the herbal supplement that has been linked to heart attacks and deaths. The lawsuit asks a federal court in New Jersey to stall the government’s ban set for April 12, and to hear new evidence.

The privately held Andover, N.J., firm is known for its Stacker 2 dietary supplements, made with ephedra. NVE calls the government’s ban “unlawful” and claims that ephedra, an adrenaline-like stimulant also known as ma huang, helps people lose weight and is safe when used as directed.

The U.S. Food and Drug Administration announced in December that it would restrict ephedra sales because ephedra poses unnecessary public health risks. This marked the first attempt to remove a dietary supplement from the market since 1994, when Congress passed a law restricting the FDA’s authority to regulate herbal products. The nation’s dietary supplement market has reached $18 billion. Ephedra products have been sold over the counter by retailers such as
Wal-Mart Stores
,
Walgreen
and
Rite Aid
.

The FDA first considered limiting sales of ephedra in 1997 after scientists and consumer advocates started to raise concerns. While pharmaceutical firms need to prove their drugs are safe with years of testing, dietary supplement makers can sell pills over the counter unless the government can prove their products are unsafe.

NVE’s suit, filed in the U.S. District Court for the District of New Jersey, asks for the court to set aside the ban because it violates the 1994 law. It also appears to set the legal groundwork for damage claims against the government. NVE claims in the suit that between 2000 and 2003 its revenues grew from $29 million to $80 million, nearly all from ephedra dietary supplements. But since the FDA moved to ban ephedra, the suit says, NVE’s sales of these products have comprised less than 5% of total sales. The states of New York, California and Illinois have already banned the selling of ephedra.

San Diego-based Metabolife International, the biggest ephedra diet pill company before it recently suspended its ephedra products, is still “weighing options,” said Jan Strode, a company spokesperson. “Metabolife believes that it’s premature to say whether they will sue,” Strode said. “We are still weighing the options and going through the paperwork.”